Tag: CFDA

Heralding an end for Changchun Changsheng Life Sciences, whose name literally means “long life,” a furious Chinese government handed out its verdict on the company’s role in a high-profile vaccine scandal that provoked nationwide anger and doomed the careers of several top-ranking government officials.

The Changchun, China-based vaccine maker will be fined a whopping 9.11 billion Chinese yuan ($1.32 billion) on eight violations of drug regulations, China’s National Medical Products Administration said in a release (Chinese) Tuesday as the agency concluded its investigation.

The sheer size of the punishment—rarely seen, if not unprecedented in China’s biopharma history—shows just how far Beijing is willing to go to placate public anger and deter future offenders that could damage its drug industry’s reputation.

Confirming what the agency had found during an on-site probe, the charges said Changsheng mixed different batches of active vaccine ingredients, including expired ones; failed to run proper efficacy tests; fabricated vaccine production dates; and manipulated or destroyed original records to cover its tracks. (cr. FiercePharma)

Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry’s biggest names.The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.

The list of “clinically urgently needed new drugs” was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China.

According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or because they’ve shown clear advantages in clinical studies.

In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.

The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of key drugs.

The government’s health department and recently rebranded drug regulator will compile and actively update a drug list that encourages companies to produce generic versions. That list will include medications for rare diseases, major infectious diseases and pediatric treatments, as well as important drugs that are running scarce.

Just months after picking up Advanced Accelerator Applications in a $3.9 billion buyout, Novartis is getting a quick boost with the U.S. approval for Lutathera. The FDA approved the first-in-class med as a treatment for rare cancers of the digestive tract the other day.

Lutathera is first the peptide receptor radionuclide therapy to win U.S. approval, according to a release from AAA. Approved to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the drug works by binding to the receptors and then using radiation to fight cancer.

Jefferies analysts have predicted $500 million to $1 billion in peak sales for the drug, while Baader Helvea analyst Bruno

Bulic has been more optimistic. At the time of the AAA acquisition by Novartis last year, he predicted $2 billion in peak sales, according to Reuters.

In a move likely to benefit Chinese citizens as well as foreign drug firms, the Chinese government has agreed to accept data from clinical trials conducted outside China for the approval of new drugs.

“Applicants can directly apply for drug listing registration after the completion of the international multicenter drug clinical trials,” the China Food & Drug Administration (CFDA) disclosed in a statement.

IMS Health, a market research firm, expects that China will account for 11% of global pharmaceutical spending by 2020. The country is already the world’s second-largest drug market after the U.S.